SYNRIBO- omacetaxine mepesuccinate injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OMACETAXINE MEPESUCCINATE (UNII: 6FG8041S5B) (OMACETAXINE - UNII:84MI6OYN4Z)

Available from:

Cephalon, LLC

INN (International Name):

OMACETAXINE MEPESUCCINATE

Composition:

OMACETAXINE MEPESUCCINATE 3.5 mg in 1 mL

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SYNRIBO is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKI). None. Risk Summary Based on its mechanism of action and findings from animal studies, SYNRIBO can cause fetal harm when administered to pregnant women. In animal reproduction studies, subcutaneous administration of omacetaxine mepesuccinate to pregnant mice during organogenesis at doses approximately 0.25 to 0.5 times the maximum recommended human doses (MRHD) resulted in embryo-fetal mortality, structural abnormalities, and alterations to growth (see Data) . There are no available data on SYNRIBO use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions (5.4)] .  The estimated background risk of major birth defects and miscarriage for the indi

Product summary:

SYNRIBO (omacetaxine mepesuccinate) for Injection is supplied in 8 mL clear glass single-dose vial in individual cartons. Each vial contains 3.5 mg of SYNRIBO (omacetaxine mepesuccinate) for Injection (NDC 63459-177-14). Store unopened vials at 20o C to 25ºC (68o F to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Prior to re-constitution, keep product in carton to protect from light. Omacetaxine mepesuccinate is a cytotoxic drug. Follow special handling and disposal procedures1 .

Authorization status:

New Drug Application

Patient Information leaflet

Cephalon, LLC
----------
MEDICATION GUIDE
SYNRIBO® (sin-RYE-bo)
(omacetaxine mepesuccinate)
for injection, for subcutaneous use
What is the most important information I should know about SYNRIBO?
SYNRIBO can cause serious side effects including:
•
Low blood counts. Low blood counts are common when using SYNRIBO,
including low red blood
cells, white blood cells, and platelets, and can be severe. If your
white blood cell count becomes very
low, you are at increased risk for infection which can lead to death.
Your healthcare provider will
check your blood counts regularly during treatment with SYNRIBO. Tell
your healthcare provider
right away if you get any of the following symptoms:
•
fever
•
chills
•
body aches
•
feeling very tired
•
shortness of breath
•
bleeding (see below)
•
Bleeding. SYNRIBO causes severe low platelet counts that may increase
your risk of severe
bleeding. Severe low platelet counts can cause you to have bleeding in
your brain that can lead to
death, or severe stomach bleeding. Your healthcare provider will check
your platelet counts regularly
during treatment with SYNRIBO. Tell your healthcare provider right
away if you get any of the
following symptoms:
•
unusual bleeding
•
easy bruising
•
blood in urine or stool
•
confusion
•
slurred speech
•
vision changes
See “What are the possible side effects of SYNRIBO?” for more
information about side effects.
What is SYNRIBO?
SYNRIBO is a prescription medicine used to treat adults with a type of
blood cancer called chronic myeloid
leukemia (CML):
•
that is in the chronic phase or accelerated phase, and
•
who have not responded to (resistant) or cannot tolerate 2 or more
medicines called tyrosine kinase
inhibitors.
It is not known if SYNRIBO is safe and effective in children.
Before using SYNRIBO, tell your healthcare provider about all of your
medical conditions, including if you:
•
have diabetes or a family history of diabetes
•
have bleeding problems
•
plan to have any dental or surgical procedures
•
are

Summary of Product characteristics

SYNRIBO- OMACETAXINE MEPESUCCINATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
CEPHALON, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SYNRIBO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SYNRIBO.
SYNRIBO (OMACETAXINE MEPESUCCINATE) FOR INJECTION, FOR SUBCUTANEOUS
USE
INITIAL U.S. APPROVAL: 2012
INDICATIONS AND USAGE
SYNRIBO for Injection is indicated for the treatment of adult patients
with chronic or accelerated phase
chronic myeloid leukemia (CML) with resistance and/or intolerance to
two or more tyrosine kinase
inhibitors (TKI) (1).
DOSAGE AND ADMINISTRATION
Induction Dose: 1.25 mg/m administered by subcutaneous injection twice
daily for 14 consecutive days
of a 28-day cycle (2.1).
Maintenance Dose: 1.25 mg/m administered by subcutaneous injection
twice daily for 7 consecutive
days of a 28-day cycle (2.2).
Dose modifications are needed for toxicity (2.3).
DOSAGE FORMS AND STRENGTHS
For Injection: Single-dose vial containing 3.5 mg of omacetaxine
mepesuccinate as a lyophilized powder
(3).
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Myelosuppression: Severe and fatal thrombocytopenia, neutropenia and
anemia. Monitor hematologic
parameters frequently (2.3, 5.1).
Bleeding: Severe thrombocytopenia and increased risk of hemorrhage.
Fatal cerebral hemorrhage and
severe, non-fatal gastrointestinal hemorrhage (5.1, 5.2).
Hyperglycemia: Glucose intolerance and hyperglycemia including
hyperosmolar non-ketotic
hyperglycemia (5.3).
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of
reproductive potential of the potential
risk to a fetus and to use an effective method of contraception (5.4,
8.1, 8.3).
ADVERSE REACTIONS
Most common adverse reactions (frequency ≥ 20%): thrombocytopenia,
anemia, neutropenia, diarrhea,
nausea, fatigue, asthenia, injection site reaction, pyrexia,
infection, and lymphopenia (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA PHARMACEUTICALS AT
1-888-483-
8279 OR FDA AT 1-800-FD